Method for the photometric analysis of test elements

• US 6,707,554 B1
• Filed: 09/04/2001
• Issued: 03/16/2004
• Est. Priority Date: 09/29/1998
• Status: Expired due to Term

• Current Assignee: Roche Diagnostics GmbH (Roche Holding AG)
• Original Assignee: Roche Diagnostics GmbH (Roche Holding AG)
• Inventors: Wersig, Christian, Zimmer, Volker, Miltner, Karl, Ruppender, Uwe
• Primary Examiner(s): Adams, Russell
• Assistant Examiner(s): SEVER, ANDREW T
• Application Number:
  US09/806,115
• Time in Patent Office: 924 Days
• Field of Search: 356/445, 356/446, 356/39-42, 356/432, 356/433, 356/441, 356/434-436, 356/448, 356/36, 356/37, 356/427
• US Class Current: 356/433
• CPC Class Codes: G01N 21/8483 Investigating reagent band test-element handling not specific to a test method G01N33/4875; analytical elements specific to chemical analysis of biological material G01N33/52; autometer with reagent band G01N35/04

Abstract

The invention concerns a method for the photometric analysis of test elements with a detection zone which is stable towards positioning tolerances of the detection zone comprising the following steps: activating the first light source to irradiate a first region of the detection zone and detecting the light reflected from the detection zone or transmitted through the detection zone in order to generate a first detection signal (50), activating the second light source to irradiate a second region of the detection zone which is displaced relative to the first region in the direction of the positioning tolerance and detecting the light reflected from the detection zone or transmitted through the detection zone in order to generate a second detection signal (60), comparing the first and the second detection signal and determining whether the first and/or the second detection signal has been obtained by illuminating an area situated completely on the detection zone. The invention also concerns a device to carry out this method and a method for the photometric analysis of a test element with detection of sample application.

Claims

1. A method for the photometric analysis of test elements having a detection zone, the method being tolerant of positioning variations of the detection zone, comprising the steps of

a) placing a test element in a holder such that the detection zone of the test element is positioned relative to an illumination unit having a first and a second light source, a positioning variation of the detection zone occurring in at least one direction,

b) contacting the detection zone with a sample such that a detection system present in the detection zone leads to a photometrically detectable change in the detection zone when an analyte is present in the sample,

c) activating the first light source to irradiate a first region of the detection zone, and detecting at least one of light reflected from the detection zone or light transmitted through the detection zone, in order to generate a first detection signal,

d) activating the second light source to irradiate a second region of the detection zone which is displaced relative to the first region in the direction of the positioning variation and detecting at least one of light reflected from the detection zone or light transmitted through the detection zone in order to generate a second detection signal,

e) comparing the first and the second detection signal and determining whether the first and/or the second detection signal has been obtained by illuminating an area situated completely on the detection zone and selecting the corresponding detection signal;

and

f) determining the analyte concentration contained in the sample by analysing the selected signal.

2. A method as claimed in claim 1, further comprising the steps of:

a) determining a first and a second base-line detection signal on an unused test element, and

b) standardizing the first and the second detection signal by division by the corresponding base-line detection signal before determining the analyte concentration in step f).

3. A method as claimed in claim 1, wherein the first region irradiated by the first light source and the second region irradiated by the second light source have essentially the same size.

4. A method as claimed in claim 1, wherein the test element is a capillary gap test element.

5. A method as claimed in claim 1, further comprising the step of:

arranging the first and second light source such that focal points of the light sources are located in a connecting line running essentially parallel to a width of the detection zone.

6. A method as claimed in claim 5, wherein the test element is a capillary gap test element containing a capillary gap, and the width is arranged essentially perpendicular to the capillary gap.

7. A method as claimed in claim 5, wherein the first region has a width d1 and the second region has a width d2, and the first and second regions overlap over a maximum width “

a”

in the direction of the connecting line whereby the following applies;

8. A method as claimed in claim 7, in which the following applies:

9. A method as claimed in claim 1, wherein the regions irradiated by the first light source and by the second light source are ovals.

10. A method as claimed in claim 1, wherein the regions irradiated by the first light source and by the second light source are rectangles.

11. A method as claimed in claims 1, 9 or 10, wherein the first and second irradiated regions overlap.

12. A method as claimed in claim 11, wherein the maximum overlap is less than half the diameter of the irradiated regions.

13. A method for the photometric analysis of test elements having a detection zone, the method being tolerant of positioning variations of the detection zone, comprising the steps of

a) placing a test element in a holder such that the detection zone of the test element is positioned relative to an illumination unit having a first and a second light source, a positioning variation of the detection zone occurring in at least one direction,

b) contacting the detection zone with a sample such that a detection system present in the detection zone leads to a photometrically detectable change in the detection zone when an analyte is present in the sample,

c) activating the first light source to irradiate a first region of the detection zone, and detecting at least one of light reflected from the detection zone or light transmitted through the detection zone, in order to generate a first detection signal,

d) activating the second light source to irradiate a second region of the detection zone which is displaced relative to the first region in the direction of the positioning variation and detecting at least one of light reflected from the detection zone or light transmitted through the detection zone in order to generate a second detection signal,

e) comparing the first and the second detection signal and determining whether the first and/or the second detection signal has been obtained by illuminating an area situated completely on the detection zone and selecting the detection signal that has a lower intensity, and

f) determining the analyte concentration contained in the sample by analysing the selected detection signal.

14. A method for the photometric analysis of test elements having a detection zone, the method being tolerant of positioning variations of the detection zone, comprising the steps of

a) placing a test element in a holder such that the detection zone of the test element is positioned relative to an illumination unit having a first and a second light source, a positioning variation of the detection zone occurring in at least one direction,

b) contacting the detection zone with a sample such that a detection system present in the detection zone leads to a photometrically detectable change in the detection zone when an analyte is present in the sample,

c) activating the first light source to irradiate a first region of the detection zone, and detecting at least one of light reflected from the detection zone or light transmitted through the detection zone, in order to generate a first detection signal,

d) activating the second light source to irradiate a second region of the detection zone which is displaced relative to the first region in the direction of the positioning variation and detecting at least one of light reflected from the detection zone or light transmitted through the detection zone in order to generate a second detection signal,

e) activating at least one further light source which irradiates a third region and detecting a change in at least one of reflected or transmitted light from the third region to detect the presence of the sample

f) comparing the first and the second detection signal and determining whether the first and/or the second detection signal has been obtained by illuminating an area situated completely on the detection zone and selecting the corresponding detection signal, and

g) determining the analyte concentration contained in the sample by analysing the selected detection signal.

15. A method as claimed in claim 14, wherein the at least one further light source emits radiation in a second wavelength range that is different from that of the first and second light sources and radiation in this second wavelength is detected in order to detect the presence of sample.

16. A method as claimed in claim 15, wherein the second wavelength range is in the range of 800 to 950 nm.

17. A method as claimed in claim 14, wherein the third region is located on the detection zone.

18. A method as claimed in claim 17, wherein the sample is brought into flow contact with the detection zone and the third region is located downstream of the first and second region.

19. A device for the photometric analysis of test elements comprising:

an illumination unit comprising at least a first and a second light source,

a holder for holding a test element with a detection zone in such a manner that the detection zone is positioned relative to the illumination unit,

a control unit which activates the first light source during a first activation phase in order to illuminate a first region of the detection zone and activates the second light source during a second activation phase in order to illuminate a second region of the detection zone,

a detection unit with at least one detector which detects light reflected from the detection zone or transmitted through the detection zone, the signal generated by the detection unit during the first activation phase being recorded as the first detection signal and the signal generated during the second activation phase being recorded as the second detection signal,

an analytical unit which compares the first and second detection signal and determines whether the first and/or the second detection signal has been obtained by illuminating a region situated completely on the detection zone, and analyses a corresponding analyte detection signal in order to determine an analyte concentration in a sample.

20. A device for the photometric analysis of test elements comprising:

an illumination unit comprising at least a first and a second light source, and at least one additional third light source which emits radiation in a second wavelength range that is different from the first and second light sources,

a holder for holding a test element with a detection zone in such a manner that the detection zone is positioned relative to the illumination unit,

a control unit which activates the first light source during a first activation phase in order to illuminate a first region of the detection zone and activates the second light source during a second activation phase in order to illuminate a second region of the detection zone,

a detection unit with at least one detector which detects light reflected from the detection zone or transmitted through the detection zone, the signal generated by the detection unit during the first activation phase being recorded as the first detection signal and the signal generated during the second activation phase being recorded as the second detection signal,

an analytical unit which compares the first and second detection signal and determines whether the first and/or the second detection signal has been obtained by illuminating a region situated completely on the detection zone, and analyses the radiation transmitted or reflected in said second wavelength range in order to determine an analyte concentration in a sample.

21. A device as claimed in claim 20, wherein the second wavelength range is 800 to 950 nm.

22. A device as claimed in claim 20, wherein the third light source irradiates a region of the detection zone which does not overlap with the first and second regions.

23. A method for the photometric analysis of a test element with detection of sample application on a flat detection zone of the test element comprising the steps

irradiating a control region of the detection zone,

supplying sample liquid to the detection zone in such a manner that a first zone of the detection zone comes into contact with sample liquid earlier than a second zone which is laterally displaced from the first zone,

monitoring radiation reflected from the control region or transmitted through the control region,

detecting presence of the sample liquid in the control region from a change of the reflected or transmitted radiation,

irradiating at least one detection region of the detection zone, wherein the detection region is nearer to the first zone than the control region,

detecting radiation reflected from or transmitted through the detection region,

generating a signal that can be recognized by a user of the test element to terminate supply of sample liquid when the presence of sample liquid is detected in the control region, and

analysing the detected radiation to determine the concentration of an analyte in the sample liquid.

24. A method as claimed in claim 23, wherein the test element includes a capillary gap.

25. A method as claimed in claim 24, wherein the capillary gap runs below the detection zone.

26. A method as claimed in claim 23, wherein the detection region is nearer to the first zone than the control region.

27. A method as claimed in claim 23, wherein the control region is irradiated with radiation that is absorbed by the sample liquid.

28. A method as claimed in claims 23 or 27, wherein the detection region is irradiated with radiation that is essentially not absorbed by sample liquid.

29. A method as claimed in claim 23, wherein the signal that can be recognized by a user is an optical and/or an acoustic signal.